FDA 510(k) Application Details - K032214

Device Classification Name	Counter, Differential Cell   More FDA Info for this Device
510(K) Number	K032214
Device Name	Counter, Differential Cell
Applicant	BOULE MEDICAL AB 1660 N.W. 65TH AVE SUITE 2 PLANTATION, FL 33313 US Other 510(k) Applications for this Company
Contact	ANDREW SWANSON Other 510(k) Applications for this Contact
Regulation Number	864.5220   More FDA Info for this Regulation Number
Classification Product Code	GKZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2003
Decision Date	01/29/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review